pain 

Diana 35 from unwanted hair. Medicinal reference book geotar

Diane 35 is one of the many oral contraceptives with antiandrogenic properties, which, in addition to its contraceptive action, has several other directions of action. So the drug is most often prescribed to women with manifestations of hyperandrogenism, i.e. who have increased levels of male sex hormones. This disease is often manifested by the following symptoms:

If everything is fine with your health and you just decided to switch to another type of contraception, then it is better to choose single-phase OK, for example, Yarina.

I must say that according to OK Diana 35, I met the most diverse reviews. Of course, girls write based on their own, often unsuccessful, experience, since few people write about positive experience (because of their happiness), although there are such.

Diana 35 reviews of "consumers".

More often, girls write that they want to have a baby or have already given birth on drug withdrawal. And indeed, doctors have a lot of experience in working with this drug. After a course of 4-6 months of continuous use of Diane 35, pregnancy occurs after cancellation. But it's different for everyone. Some have to take the drug for more than a year, others just a couple of months to achieve the desired result. In any case, you need to coordinate your treatment with your doctor, he must know all your chronic diseases in order to decide whether you can use this drug.

However, often girls write about Diana 35 reviews that they have side effects. Often they describe it as drug intolerance, ie. there is nausea, vomiting from the first days of admission, headaches and skin rashes. In this case, you must stop taking the pills and be sure to consult a specialist.

If you tolerate this drug well, then be sure of a positive result during its use or after its withdrawal. After all, the main thing is your desire.

Both active ingredients that are part of Diane-35 have a positive effect on the state of hyperandrogenism. Cyproterone acetate is a competitive androgen receptor antagonist, it inhibits the synthesis of androgens and determines the decrease in the concentration of these hormones in the blood due to the antigonadotropic effect. This antigonadotropic effect is enhanced by ethinylestradiol, which also regulates the synthesis of sex steroid-binding globulin (SHBG) in plasma. With this in mind, the level of unbound biologically available androgen in the blood decreases.
When using the drug Diane-35 (usually after 4 months of therapy), acne is eliminated, excessive oiliness of hair and skin disappears even earlier. Hair loss, which often accompanies seborrhea, is also reduced. When using the drug by persons with mild forms of hirsutism (primarily with mild facial hair), the results of therapy should be expected only after a few months from its start.
The contraceptive effect of Diane-35 is based on the interaction of various factors, the most important of which are ovulation suppression and changes in cervical secretion. In addition to preventing pregnancy, the drug has a number of positive properties. The menstrual cycle becomes more regular, menstruation is less painful, blood loss is reduced. The latter helps to reduce the frequency of iron deficiency anemia.
The toxicity profile of ethinylestradiol is well understood. There are no preclinical data that supplement the information regarding the safety of ethinylestradiol indicated in the sections of the instructions for medical use of the drug.
Data from standard preclinical toxicity studies with repeated use of cyproterone acetate do not indicate the existence of any specific risk to the human body.
Available clinical experience does not suggest an increase in the incidence of liver tumors in humans. The results of studies of the carcinogenicity of cyproterone acetate, conducted in rodents, do not indicate the existence of any specific carcinogenic effect. However, it should be taken into account that sex steroids may promote the growth of certain pre-existing hormone-dependent tumors.
The available data do not give grounds to object to the use of the drug Diane-35 in humans when taken according to the directions provided and at the recommended dose.
Cyproterone acetate
After oral administration of cyproterone acetate is rapidly and completely absorbed. Its peak serum concentration is 15 ng / ml and is reached approximately 1.6 hours after a single dose. The bioavailability of cyproterone acetate is approximately 88%.
Cyproterone acetate is almost completely bound to serum albumin. Only 3.5-4% of the total concentration of the steroid remains in the unbound state. The increase in SHBG levels induced by ethinylestradiol does not affect protein binding of cyproterone acetate.
Cyproterone acetate is almost completely metabolized. The main metabolite in blood plasma is 15b-OH-CPA. The rate of clearance from blood serum is approximately 3.6 ml / min / kg.
The concentration of cyproterone acetate in serum decreases biphasically, with half-lives of 0.8 hours and 2.3-3.3 days. Some of the steroid is excreted unchanged. Metabolites are excreted in the urine and bile in a ratio of 1:2. The half-life of metabolites is 1.8 days.
Taking into account the long half-life of cyproterone acetate from the blood serum, its accumulation in the blood serum can be observed during one cycle of therapy with a coefficient of 2-2.5.
Ethinylestradiol
Adsorption
When taken orally, ethinylestradiol is rapidly and completely absorbed. The peak serum concentration of approximately 71 pg/mL is reached after 1.6 hours.
Distribution
Ethinylestradiol binds strongly, yet non-specifically, to serum albumin (approximately 98%) and induces an increase in serum SHBG concentration.
Ethinylestradiol is metabolized mainly by aromatic hydroxylation, with the formation of a large number of hydroxylated and methylated metabolites, among which there are both free metabolites and conjugates with glucuronides and sulfates. Clearance is 2.3-7 ml / min / kg.
The level of ethinylestradiol in the blood serum decreases in 2 phases with half-lives of approximately 1 and 10-20 hours, respectively. The substance is not excreted unchanged from the body, ethinylestradiol metabolites are excreted in the urine and bile in a ratio of 4:6. The half-life of metabolites is approximately 1 day.
Steady-state concentration is reached in the second half of the cycle of administration, when the level of the active substance in the blood serum is 60% higher compared to a single dose.

Indications for the use of the drug Diane-35

Treatment of androgen-dependent diseases in women, such as acne, especially pronounced forms and forms accompanied by seborrhea, inflammation or nodule formation (papular-pustular acne, nodular cystic acne), with androgenetic alopecia and mild forms of hirsutism.

The use of the drug Diane-35

The drug Diane-35 is intended for regular use in order to achieve a therapeutic effect and the necessary contraceptive protection. The use of other hormonal contraceptives should be discontinued. The method of using the drug Diane-35 does not differ from the usual regimen for taking most combined oral contraceptives. With this in mind, you should follow the same instructions regarding the method of application of the drug. Irregular intake of Diane-35 can cause intermenstrual bleeding and impair therapeutic and contraceptive efficacy.
If hormonal contraceptives were not used in the previous period (last month)
Reception of a dragee should be begun in the 1st day of a menstrual cycle. You can start taking it from the 2-5th day, however, in this case, during the first cycle, it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the drug.
Switching from another combined oral contraceptive (COC)
It is advisable to start taking Diane-35 the next day after taking the last active tablet of the previous COC, at least no later than the next day after the break in taking the tablets or after taking the placebo tablets of her previous COC.
Switching from a progestogen-only method (mini-pills, injections, implants) or a progestogen intrauterine system
You can start taking Diane-35 on any day after you stop taking the minipill (with an implant or intrauterine system - on the day of their removal; in the case of an injection - instead of the next injection). However, in all cases, it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the dragee.
After an abortion in the first trimester of pregnancy
You can start using Diane-35 immediately. In this case, she does not need to use additional contraceptives.
After childbirth or abortion in the second trimester of pregnancy
In case of breastfeeding, see subsection “ During pregnancy and breastfeeding".
It is necessary to recommend starting Diane-35 from 21-28 days after childbirth or abortion in the second trimester of pregnancy. With a later start of taking the dragee, you should additionally use a barrier method of contraception during the first 7 days of taking the drug. However, if sexual intercourse has already taken place, then before starting the use of COCs, it is necessary to exclude pregnancy or wait for menstruation.
What to do if you miss a pill
If the delay in taking the dragee does not exceed 12 hours, the contraceptive effect of the drug is not reduced. Missed tablets should be taken as soon as possible. The next dragee from this package is taken at the usual time.
If the delay in taking the missed tablet exceeds 12 hours, contraceptive protection may decrease. In this case, you can be guided by two basic rules:

  • a break in taking dragees can never exceed 7 days;
  • adequate inhibition of the hypothalamus - pituitary - ovaries system is achieved by continuous intake of dragees for 7 days.

Accordingly, the following recommendations should be followed in everyday life:

  • 1st week
    You should take the last missed tablet as soon as possible, even if you have to take 2 tablets at the same time. After that, continue to take the pills at the usual time. In addition, for the next 7 days, you must use a barrier method of contraception, such as a condom. If sexual intercourse took place in the previous 7 days, the probability of pregnancy should be taken into account. The more pills missed and the closer the break in taking the drug, the higher the likelihood of pregnancy.
  • 2nd week
    You should take the last missed tablet as soon as possible, even if you have to take 2 tablets at the same time. After that, continue to take the pills at the usual time. Provided that the pills are taken correctly for 7 days before the first pass, there is no need to use additional contraceptives. In another case, or if more than 1 tablet is missed, it is recommended to additionally use a barrier method of contraception for 7 days.
  • 3rd week
    The risk of a decrease in reliability increases as a break in taking pills approaches. However, if the regimen of pills is followed, a decrease in contraceptive protection can be avoided. If one of the following options is followed, then there will be no need to use additional contraceptives, provided that the pills are taken correctly for 7 days before the pass. If this is not the case, the first of the following options should be followed and additional methods of contraception should be used for the next 7 days.

You should take the last missed tablet as soon as possible, even if you have to take 2 tablets at the same time. After that, continue to take the pills at the usual time. Dragees from the next package must be taken immediately after the end of the previous one, that is, there should be no breaks between packages. It is unlikely that menstrual-like bleeding will begin by the end of the second pack, although spotting or breakthrough bleeding is possible while taking the dragee.
You may also be advised to stop taking the pills from the current package. In this case, a break in taking the drug should be up to 7 days, including the days of skipping dragees; reception of a dragee needs to be begun from the following packing.
If the pills are missed and the patient does not have menstrual bleeding during the first usual break in taking the pills, the possibility of pregnancy should be excluded.
Recommendations for disorders of the gastrointestinal tract
In severe violations of the gastrointestinal tract, incomplete absorption of the drug is possible; in this case, additional contraception should be used.
If vomiting occurs within 3-4 hours after taking the pills, it is advisable to use the recommendations regarding skipping the pills. If a woman does not want to change her usual dosage regimen, she needs to take additional tablet(s) from another package.
How to change the time of your period or how to delay your period
To delay the onset of menstruation, you should continue to take Diane-35 pills from a new package and do not take a break in taking the drug. If desired, the reception period can be extended until the end of the second package. However, breakthrough bleeding or spotting cannot be ruled out. The usual intake of the drug is restored after a 7-day break in taking the dragee.
To shift the time of the onset of menstruation to another day of the week, it is recommended to shorten the break in taking pills by the desired number of days. It should be noted that the shorter the break, the more often the absence of menstrual-like bleeding and breakthrough bleeding or spotting during the reception of the dragee from the second package (as in the case of a delay in the onset of menstruation).

Contraindications to the use of Diane-35

COC should not be used in the presence of at least one of the following conditions or diseases. If any of these conditions or diseases occur for the first time during the use of COCs, the drug should be stopped immediately.
Venous or arterial thrombotic/thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular disorders at present or in history.
The presence or history of prodromal symptoms of thrombosis (transient cerebrovascular accident, angina pectoris).
Migraine with a history of focal neurological symptoms.
Diabetes mellitus with vascular damage.
The presence of severe or multiple risk factors for venous or arterial thrombosis may also be a contraindication (see).
Current pancreatitis or history of pancreatitis if associated with severe hypertriglyceridemia.
Current or history of severe liver disease until liver function tests return to normal.
Liver tumors (benign or malignant) - diagnosed or present in history.
Diagnosed or suspected malignant tumors (for example, genital or mammary glands), dependent on sex hormones.
Vaginal bleeding of unknown etiology.
Diagnosed or suspected pregnancy.
Hypersensitivity to the active substances or to any of the components of the drug.
The drug Diane-35 is not prescribed to men.

Side effects of Diane-35

Side effects have been reported with the use of Diane-35, but their relationship with the use of the drug has not been confirmed or refuted:

Organs and systems
Frequent (≥1/100)
Uncommon (≥1/1000 and ≤/100)
Single (≤1/1000)

contact lens intolerance

Nausea, abdominal pain

Vomiting, diarrhea

The immune system

Hypersensitivity

Study

Weight gain

Weight loss

Metabolism and malnutrition

Fluid retention

Mental disorders

Depression, mood disorder

Decreased libido

Increased libido

Reproductive system and mammary glands

Changes in vaginal secretion, the appearance of secretion from the mammary glands

Skin and subcutaneous tissue

Skin rashes, urticaria

Erythema nodosum, exudative erythema multiforme

Special instructions for the use of the drug Diane-35

Clinical data regarding estrogen/progestogen combinations such as Diane-35 are based on experience with COCs. With this in mind, the following cautions regarding the use of COCs also apply to this drug.
In the presence of any of the following conditions / risk factors, it is necessary to evaluate the benefits of using Diane-35 and the possible risk, taking into account the individual characteristics of each patient, and discuss this with her before she decides to take the drug. If any of the conditions or risk factors listed below worsen, worsen, or occur for the first time, it is recommended to consult a doctor. The doctor must decide whether to stop the use of Diane-35.
Circulatory disorders
Based on the results of epidemiological studies, there is an association between COC use and an increased risk of venous and arterial thrombotic and thromboembolic diseases such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. These conditions rarely occur.
Venous thromboembolism (VTE), manifested as venous thrombosis and/or pulmonary embolism, may occur with any COC. The risk of venous thromboembolism is highest during the 1st year of COC use. The incidence of VTE in patients taking oral contraceptives with a low dose of estrogen (≤0.05 mg ethinyl estradiol) is up to 4 cases per 10,000 women/year compared with 0.5-3 cases per 10,000 women/year in women not using oral contraceptives. The frequency of VTE associated with pregnancy is 6 cases per 10,000 women/year.
Thrombosis of other blood vessels, such as arteries and veins of the liver, kidneys, mesenteric vessels, vessels of the brain or retina, has been reported extremely rarely in women using COCs. There is no consensus regarding the relationship of these complications with the use of COCs.
Symptoms of venous or arterial thrombotic / thromboembolic events or stroke can be: unilateral pain in the lower extremities or their swelling; sudden severe chest pain radiating to the left arm; sudden shortness of breath; sudden onset cough; any unusual, severe, prolonged headache; sudden decrease or complete loss of vision; diplopia; speech disorder or aphasia; vertigo; collapse with or without partial epileptic seizure; weakness or very pronounced sudden numbness of one side or one part of the body; dysmotility; symptoms of an acute abdomen.
Factors that increase the risk of venous or arterial thrombotic/thromboembolic events or stroke:

  • age;
  • tobacco smoking (in combination with heavy smoking and with age, the risk increases, especially in women over the age of 35);
  • family history (for example, cases of venous or arterial thromboembolism in siblings or parents at a relatively early age). If a hereditary predisposition is suspected, before a decision is made on the use of any PDA, the patient should be referred for a consultation with an appropriate specialist;
  • obesity (body mass index - more than 30 kg / m2);
  • dyslipoproteinemia;
  • AG (arterial hypertension);
  • pathology of the heart valves;
  • atrial fibrillation;
  • prolonged immobilization, radical surgery, any surgery on the lower extremities, significant trauma. In these cases, it is recommended to stop the use of COCs (for elective operations at least 4 weeks before they are carried out) and not to restore it earlier than 2 weeks after complete remobilization.

There is no consensus on the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism.
It is necessary to take into account the increased risk of thromboembolism in the postpartum period.
Other diseases that may be associated with serious circulatory disorders include: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the incidence of migraine or its exacerbation during the period of COC use (which may be a precursor to cerebrovascular accident) requires an urgent cessation of COC use.
Biochemical parameters characteristic of a hereditary or acquired tendency to venous or arterial thrombosis include: resistance to activated protein C (APC), hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies).
When analyzing the risk/benefit ratio, the physician should take into account that adequate treatment for the conditions mentioned above can reduce the associated risk of thrombosis, as well as the fact that the risk of pregnancy-associated thrombosis is higher than with COCs. at low doses (≤0.05 mg ethinyl estradiol).
Tumors
The most important risk factor for developing cervical cancer is the persistence of papillomavirus. The results of some epidemiological studies suggest an additional increase in this risk with long-term use of COCs, however, this statement is controversial, since it is not completely clear how the results of studies take into account concomitant risk factors, such as taking a cervical smear and sexual behavior, including the use of barrier methods of contraception .
The results of a meta-analysis based on data obtained in 54 epidemiological studies indicate a slight increase in the relative risk (RR = 1.24) of developing breast cancer in women using COCs. This increased risk gradually disappears within 10 years after the end of COC use. Since breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women who currently use or have recently used COCs is insignificant relative to the overall risk of developing breast cancer. The results of these studies do not provide evidence for the existence of a causal relationship. The increased risk may be due to both the earlier diagnosis of breast cancer in women using COCs, the biological effect of COCs, or a combination of both factors. A trend has been noted that breast cancer detected in women who have ever taken COCs is clinically less pronounced than in those who have never taken COCs.
In isolated cases, benign, and even less often, malignant liver tumors were noted in women using COCs, which sometimes led to life-threatening intra-abdominal bleeding. If there are complaints of severe pain in the epigastric region, liver enlargement or signs of intra-abdominal bleeding in differential diagnosis, the possibility of a liver tumor in women taking COCs should be considered.
Other states
Women with hypertriglyceridemia or a family history of this disorder are at risk of developing pancreatitis when taking COCs.
Although a slight increase in blood pressure has been reported in many women taking COCs, a clinically significant increase in blood pressure is a single occurrence. However, if prolonged clinically significant hypertension (arterial hypertension) occurs while taking a COC, then it is sometimes advisable to stop the COC and direct treatment to hypertension (arterial hypertension).
The occurrence or exacerbation of the following diseases during pregnancy and with the use of COCs has been reported, but their relationship with the use of COCs has not been conclusively established: jaundice and / or itching associated with cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham's chorea, herpes of pregnancy, hearing loss associated with otosclerosis.
In acute or chronic liver dysfunction, it may be necessary to stop taking COCs until liver function tests return to normal. In case of recurrence of cholestatic jaundice, which first occurred during pregnancy or previous use of sex hormones, COC should be discontinued.
Although COCs can affect peripheral insulin resistance and glucose tolerance, there is no evidence of the need to change the therapeutic regimen in women with diabetes taking low doses of COCs (containing ≤0.05 mg of ethinyl estradiol). However, diabetic women should be closely monitored while taking COCs.
Crohn's disease and ulcerative colitis may be associated with COC use.
Occasionally, chloasma may occur, especially in women with a history of chloasma of pregnancy. Women who are prone to chloasma should avoid exposure to direct sunlight or ultraviolet radiation while taking COCs.
medical examination
Before starting or restoring Diane-35 intake, a complete medical examination should be carried out and the patient's history should be studied in detail, taking into account contraindications (see) and warnings (see). When using COCs, it is recommended to conduct periodic examinations, which is very important, since contraindications (for example, transient circulatory disorders, etc.) or risk factors (for example, a family history of venous or arterial thrombosis) may first occur while taking the drug.
The frequency and nature of these examinations should be based on existing norms of medical practice, taking into account the individual characteristics of each woman, however, special attention is paid to the examination of the pelvic organs, including the standard analysis of the cytology of the cervix, abdominal organs, mammary glands, determination of blood pressure.
It is necessary to warn a woman that Diane-35, like other oral contraceptives, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reduced efficiency
The effectiveness of Diane-35 may decrease if a tablet is missed, gastrointestinal dysfunction or the use of other drugs.
Cycle control
When taking oral contraceptives, intermenstrual bleeding (spotting or breakthrough bleeding) may occur, especially during the first few months of treatment. With this in mind, the examination with the appearance of any intermenstrual bleeding should be carried out only after a period of adaptation of the body to the drug, which is approximately 3 cycles.
If cycle disturbances continue or recur after several normal cycles, non-hormonal causes of bleeding should be considered and appropriate investigations carried out to exclude the presence of a tumor or pregnancy. Diagnostic measures can include curettage.
In some women, menstrual bleeding may not occur during a break in taking the drug. When taking COCs as directed, pregnancy is unlikely. However, if the contraceptive is taken irregularly or if menstrual bleeding is absent for 2 cycles, pregnancy must be excluded before continuing to take the COC.
During pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy. In the event of pregnancy during the use of Diane-35, the drug should be discontinued. However, according to the results of embryotoxicity studies using a combination of two active components of the drug, no confirmation of the teratogenic effect of the drug during organogenesis was found. Although the use of high doses of cyproterone acetate during the hormone-sensitive phase of genital differentiation causes the appearance of female sexual characteristics in male fetuses, during the observation of newborn boys whose mothers took cyproterone acetate during pregnancy, no female sexual characteristics were detected.
The use of Diane-35 is contraindicated during lactation. Cyproterone acetate passes into breast milk. About 0.25% of the dose of cyproterone acetate taken by the mother enters the child's body with milk, which corresponds to 1 μg / kg of body weight and 0.2% of the daily dose of ethinyl estradiol.
Influence on the ability to drive vehicles and work with mechanisms
No influence noted.

Diane-35 drug interactions

The interaction of drugs containing a combination of estrogen / progestogen (such as Diane-35) and other drugs can lead to breakthrough bleeding and / or loss of contraceptive effectiveness. The following interactions are reported in the literature.
Hepatic metabolism: interactions with drugs that induce microsomal enzymes may occur, which may cause increased clearance of sex hormones (eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and drugs containing St. John's wort) .
Interaction with enterohepatic circulation: the results of some clinical studies suggest that the enterohepatic circulation of estrogens may be reduced when taking certain antibiotics that reduce the concentration of ethinylestradiol (for example, antibiotics of the penicillin and tetracycline series).
When treated with any of the above drugs, a woman should temporarily use a barrier method in addition to taking Diane-35 or choose another method of contraception. When treating with drugs that induce microsomal enzymes, the barrier method should be used throughout the entire period of treatment with the corresponding drug and for another 28 days after stopping its use. When treated with antibiotics (excluding rifampicin and griseofulvin), the barrier method should be used for another 7 days after antibiotic withdrawal. If the barrier method is still being used, and the pills in the Diane-35 package have already run out, taking the pills from the next package should be started without the usual break.
Oral contraceptives containing estrogen/progestogen (such as Diane-35) may interfere with the metabolism of other drugs. Therefore, the concentrations of active substances in blood plasma and tissues (for example, cyclosporine) may change.
Note. To establish the potential for interaction with drugs that are prescribed simultaneously with Diane-35, it is recommended that you read the instructions for the medical use of these drugs.
Impact on laboratory results
Taking contraceptives such as Diane-35 may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma levels of proteins (carriers) such as sex-binding globulin hormones and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, as well as parameters of coagulation and fibrinolysis.

Diane-35 overdose, symptoms and treatment

No serious adverse effects due to overdose have been reported. Overdose symptoms are possible: nausea, vomiting, and in young girls - slight bleeding from the vagina. There are no specific antidotes treatment should be symptomatic.

Storage conditions for Diane-35

At a temperature not higher than 30 °C.

List of pharmacies where you can buy Diane-35:

  • Saint Petersburg

Diane-35 - a new description of the drug, you can read the contraindications, side effects, dosage of the drug Diane-35. Reviews about Diana-35 -

Combined low-dose monophasic oral contraceptive with antiandrogenic effect.
Preparation: DIANE-35
The active substance of the drug: cyproterone, ethinylestradiol
ATX encoding: G03HB01
CFG: Monophasic oral contraceptive with antiandrogenic properties
Registration number: P No. 012240/01
Date of registration: 29.12.06
The owner of the reg. Award: SCHERING AG (Germany)

Diane-35 release form, drug packaging and composition.

Dragee
1 dragee
ethinylestradiol
35 mcg
cyproterone acetate
2 mg

Excipients: lactose monohydrate, corn starch, polyvidone 25,000, magnesium stearate, sucrose, polyvidone 700,000, macrogol 6000, calcium carbonate precipitated, talc, 85% glycerol, titanium dioxide, iron oxide yellow, iron oxide red, motaglycol wax.

21 pcs. - cellular contour packaging (1) - packs of cardboard.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action of Diane-35

Combined low-dose monophasic oral contraceptive with antiandrogenic effect, containing estrogen - ethinyl estradiol and antiandrogen with progestogenic activity - cyproterone acetate.
Cyproterone acetate contained in Diana-35 inhibits the influence of androgens, which are also produced in the female body. Thus, it becomes possible to treat diseases caused by increased production of androgens or specific sensitivity to these hormones.
Against the background of taking Diane-35, the increased activity of the sebaceous glands, which plays an important role in the occurrence of acne and seborrhea, decreases. After 3-4 months of therapy, this usually leads to the disappearance of the existing rash. Excessive oiliness of hair and skin disappears even earlier. It also reduces hair loss, which often accompanies seborrhea. Diane-35 therapy in women of reproductive age reduces the clinical manifestations of mild forms of hirsutism; however, the effect of the treatment should be expected only after several months of use.
Along with the antiandrogenic effect described above, cyproterone acetate also has a pronounced progestogenic effect.
The contraceptive effect of Diane-35 is based on the interaction of various factors, the most important of which are the inhibition of ovulation and changes in the secretion of cervical mucus.
The cycle becomes more regular, painful periods are less common, bleeding intensity decreases, resulting in a reduced risk of iron deficiency anemia.

Pharmacokinetics of the drug.

Cyproterone acetate
Suction
After taking Diane-35 cyproterone acetate is completely absorbed from the gastrointestinal tract. Bioavailability - 88%. After ingestion of 1 tablet of Diane-35 Cmax is reached after 1.6 hours and is 15 ng / ml.
Distribution
Cyproterone acetate is almost completely bound to plasma albumin, approximately 3.5-4.0% is in the free state. Since protein binding is nonspecific, changes in the level of sex steroid-binding globulin (SHBG) do not affect the pharmacokinetics of cyproterone acetate. Up to 0.2% of the dose of cyproterone acetate is excreted in breast milk.
Metabolism and excretion

Pharmacokinetics of the drug.

cyproterone acetate is biphasic with a T1 / 2 of 0.8 h and 2.3 days, respectively, for the first and second phases. The total plasma clearance is 3.6 ml/min/kg. Biotransformed by hydroxylation and conjugation, the main metabolite is the 15b-hydroxyl derivative. It is excreted mainly in the form of metabolites with urine and bile in a ratio of 1: 2, a small part - unchanged with bile. T1 / 2 for cyproterone acetate metabolites is 1.8 days.
Ethinylestradiol
Suction
After taking Diane-35, ethinylestradiol is rapidly and completely absorbed from the gastrointestinal tract. In the process of absorption and primary passage through the liver, ethinylestradiol undergoes intensive metabolism, which leads to a bioavailability of approximately 45% and its significant individual variability. After oral administration of 1 tablet Diane-35 Cmax is approximately 80 pg / ml and is reached after 1.7 hours.
Distribution
Binding to proteins (albumin) of blood plasma is high (2% are in the plasma in a free form). Vd is approximately 5 l/kg. Up to 0.02% of the dose of ethinyl estradiol is excreted in breast milk. Ethinylestradiol increases hepatic synthesis of SHBG and CCG (corticosteroid-binding globulin) during continuous administration. During treatment with Diane-35, the serum concentration of SHBG increased from approximately 100 nmol / l to 300 nmol / l, and the serum concentration of CSH increased from approximately 50 μg / ml to 95 μg / ml.
Metabolism and excretion

Pharmacokinetics of the drug.

ethinylestradiol is biphasic, with a T1 / 2 of 1-2 hours and approximately 20 hours, respectively. Plasma clearance - about 5 ml / min / kg. Ethinylestradiol is excreted from the body as metabolites; about 40% - with urine, 60% - with bile.

Indications for use:

- contraception in women with androgenization phenomena;
- androgen-dependent diseases in women: acne (especially their pronounced forms, accompanied by seborrhea, inflammatory phenomena with the formation of nodes / papular-pustular acne, nodular cystic acne /), androgenetic alopecia and mild forms of hirsutism.

Dosage and method of application of the drug.

Diane-35 is taken orally 1 tablet / day. Dragees are taken without chewing and washed down with a small amount of liquid. The time of taking the drug does not play a role, but the subsequent dose should be taken at the same selected hour, preferably after breakfast or dinner.
Diane-35 intake is started on the 1st day of the cycle, using pills of the corresponding day of the week from the calendar package.
The daily intake of the drug is carried out using dragees from the calendar package sequentially in the direction of the arrow printed on the foil until all the dragees are taken. After the end of taking all 21 pills from the calendar package, a break is made in taking the drug for 7 days, during which menstrual bleeding occurs.
After 28 days from the start of taking the drug (21 days of admission and 7 days off), i.e. on the same day of the week as at the beginning of the course, continue taking the drug from the next package.
When switching from combined oral contraceptives, Diane-35 should be started the next day after taking the last pill with the active components of the previous drug, but in no case later than the next day after the usual 7-day break in taking (for drugs containing 21 pills) . Further according to the scheme described above. If the patient has taken the previous contraceptive daily for 28 days, Diane-35 should be started after taking the last inactive dragee.
When switching from contraceptives containing only gestagens (“mini-pills”), Diane-35 can be used without interruption. When using injectable forms of contraceptives, Diane-35 begins to be taken from the day the next injection is to be made. When switching from an implant - on the day of its removal. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the dragee.
After an abortion in the first trimester of pregnancy, a woman can start taking the drug immediately. In this case, the woman does not need additional methods of contraception.
After childbirth or abortion in the II trimester of pregnancy, the drug should be started on the 21-28th day. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.
If a woman had a sexual life between childbirth or abortion and the start of taking Diane-35, then pregnancy should first be excluded or it is necessary to wait for the first menstruation.
A woman should take the missed pill as soon as possible, the next pill is taken at the usual time. If the delay is less than 12 hours, the reliability of contraception does not decrease. If the delay in taking the pills was more than 12 hours, the reliability of contraception may be reduced. It should be borne in mind that taking pills should never be interrupted for more than 7 days, and that 7 days of continuous pills are required to achieve adequate suppression of the function of the hypothalamic-pituitary-ovarian system.
If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the first and second weeks of taking the drug, then the woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next dragee is taken at the usual time. Additionally, you should use a barrier method of contraception for the next 7 days.
If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the third week of taking the drug, then the woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time ). The next dragee is taken at the usual time. In addition, taking pills from a new package should be started as soon as the current package is over, i.e. nonstop. It is most likely that the woman will not have withdrawal bleeding until the end of the second pack, but she may experience spotting or breakthrough bleeding on the days of taking the pills.
If a woman has had vomiting within 3 to 4 hours after taking Diane-35, absorption of the active substances may be incomplete. In this case, it is necessary to focus on the recommendations when skipping the dragee.
In order to delay the onset of menstruation, a woman should continue taking the pills from the new Diane-35 package immediately after taking all the pills from the previous one, without interrupting the intake. Dragees from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume taking Diane-35 from a new package should be after the usual 7-day break.
In order to move the day of the start of menstruation to another day of the week, a woman should shorten the next break in taking pills by as many days as she wants. The shorter the interval, the greater the risk that she will not have withdrawal bleeding and, in the future, will have spotting and breakthrough bleeding during the second pack (as well as if she would like to delay the onset of menstruation).
In the treatment of hyperandrogenic conditions, the duration of administration is determined by the severity of the disease. After the disappearance of symptoms, it is recommended to take Diane-35 for at least another 3-4 months. In the event of a relapse a few weeks or months after the completion of the course, repeated therapy with Diane-35 can be performed.

Side effect of Diane-35:

From the endocrine system: in rare cases - engorgement, soreness, enlargement and discharge from the mammary glands, changes in body weight.
From the reproductive system: in rare cases - intermenstrual bleeding, changes in vaginal secretions, changes in libido.
From the side of the central nervous system: in rare cases - headache, migraine, decreased mood.
From the digestive system: in rare cases - nausea, vomiting.
Other: in very rare cases - poor tolerance to contact lenses, allergic reactions, the appearance of age spots on the face (chloasma).
These side effects may develop in the first few months of taking Diane-35 and usually decrease over time.

Contraindications to the drug:

- thrombosis and thromboembolism, incl. in history (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris);
- diabetes mellitus complicated by microangiopathies;
- the presence of severe or multiple risk factors for venous or arterial thrombosis;
- diseases or severe violations of liver function;
- liver tumors (including history);
- hormone-dependent malignant tumors, incl. tumors of the breast or genital organs (including history);
- uterine bleeding of unknown etiology;
- pancreatitis (including history), if it was accompanied by severe hypertriglyceridemia;
- the presence of a history of migraine, which was accompanied by focal neurological symptoms;
- lactation;
- pregnancy or suspicion of it;
- Hypersensitivity to the components of the drug.
If any of these conditions develop for the first time while taking Diane-35, the drug should be immediately discontinued.

Use during pregnancy and lactation.

Diane-35 is contraindicated for use during pregnancy and lactation.

Special instructions for the use of Diane-35.

Before starting the use of Diane-35, it is necessary to conduct a general medical examination (including the mammary glands and a cytological examination of cervical mucus), exclude pregnancy, disorders of the blood coagulation system. With prolonged use of the drug, preventive control examinations should be carried out every 6 months.
In the presence of risk factors, the potential risk and expected benefit of therapy should be carefully assessed and discussed with the woman before she decides to start taking the drug. With aggravation, intensification, or at the first manifestation of any of these conditions or risk factors, drug withdrawal may be required.
The approximate incidence of venous thromboembolism (VTE) when taking oral contraceptives with a low dose of estrogen (less than 50 micrograms of ethinyl estradiol) is up to 4 per 10,000 women per year, compared with 0.5-3 per 10,000 women who do not take oral contraceptives. At the same time, the frequency of VTE when taking combined oral contraceptives is less than the frequency of VTE associated with pregnancy (6 per 10,000 pregnant women per year).
The patient should be warned that with the development of symptoms of venous or arterial thrombosis, you should immediately consult a doctor. These symptoms include unilateral leg pain and/or swelling; sudden severe chest pain, with or without radiating to the left arm; sudden shortness of breath; sudden onset of coughing; any unusual, severe, prolonged headache; increased frequency and severity of migraine; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; dizziness; collapse with or without partial seizure; weakness or very significant loss of sensation that suddenly appeared on one side or in one part of the body; movement disorders; symptom complex "acute" abdomen.
The relationship between taking combined oral contraceptives and arterial hypertension has not been established. If persistent arterial hypertension occurs, Diane-35 should be canceled and appropriate antihypertensive therapy prescribed. Reception of a contraceptive can be continued with the normalization of blood pressure.
If abnormal liver function occurs, Diane-35 may need to be temporarily discontinued until laboratory parameters return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.
Although combined oral contraceptives have an effect on tissue resistance to insulin and glucose tolerance, it is usually not necessary to adjust the dose of hypoglycemic drugs in patients with diabetes mellitus. However, this category of patients should be under close medical supervision.
Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
If symptoms in women with hirsutism have developed recently or have increased significantly, other causes, such as an androgen-producing tumor, congenital adrenal dysfunction, should be considered in the differential diagnosis.
While taking Diane-35, irregular bleeding (spotting or breakthrough bleeding) can sometimes occur, especially during the first months of therapy. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately 3 cycles.
If irregular bleeding recurs or develops after previous regular cycles, then non-hormonal causes should be considered and adequate diagnostic measures taken to exclude malignant neoplasms or pregnancy. These may include diagnostic curettage.
In some cases, withdrawal bleeding may not develop during a break in taking the pills, with irregular intake of pills or in the absence of two menstrual-like bleeding in a row, pregnancy should be excluded before continuing to take the drug.

Drug overdose:

Symptoms: nausea, vomiting, slight vaginal bleeding (in girls).
Treatment: carry out symptomatic therapy. There is no specific antidote.

Interaction of Diane-35 with other drugs.

With the simultaneous use of Diane-35 and drugs inducers of microsomal liver enzymes (hydantoins, barbiturates, primidone, carbamazepine and rifampicin; and possibly with oxcarbazepine, topiramate, felbamate and griseofulvin), the clearance of ethinylestradiol and cyproterone increases, which can lead to breakthrough uterine bleeding or decrease in the reliability of contraception.
With simultaneous use with ampicillins and tetracyclines, the contraceptive reliability of Diane-35 is reduced.

Terms of storage conditions of the drug Diane-35.

The drug should be stored at room temperature. Shelf life - 5 years.

Diane-35 (ethinyl estradiol + cyproterone acetate) is a low-dose contraceptive tablet. Created by the German pharmaceutical company Schering AG. It is used to minimize the effect of androgens on the body of a woman, as well as a contraceptive in women with increased secretion of androgens or hypersensitivity to them. Acetate, which is part of the drug cyproterone, inactivates androgen receptors, which become insensitive to androgens synthesized in the adrenal glands, ovaries and skin. At the same time, their own androgens lose their affinity for receptors and can no longer stimulate skin derivatives (sebaceous glands and hair follicles). The state and functional activity of skin derivatives is largely determined by androgens: with an increase in the level of the latter, sebum secretion increases and intensive growth of male-type hair on the body begins, while hair on the head begins to thin. Increased sebum secretion on the skin of the face and head is reinforced by a violation of the secretion of the sebaceous glands and a change in the chemical formula of sebum, which ultimately leads to seborrhea. In addition, male sex hormones contribute to blockage of the sebaceous glands, as a result of which the skin becomes covered with acne, incl. with signs of inflammation. Androgens also affect the so-called. "vellus" hair, which increases in diameter, becomes darker in color, lengthens and begins to grow in traditionally "male" areas - above the upper lip, on the chest, back, chin, arms and legs. This phenomenon is called hirsutism. The most effective treatment for conditions associated with androgen hypersecretion or hypersensitivity is the use of antiandrogen drugs. Throughout the entire antiandrogenic drug course, in cases where guaranteed contraception is required, drugs that are both contraceptives and antiandrogens become the best option. Diane-35 possesses these qualities.

The drug effectively relieves hirsutism, acne, seborrhea. Duration of admission - 6-9 months. One package is enough for 28 days. In such cases, the duration of pharmacotherapy increases to 9-12 months. Diana-35 should be continued for another 3-4 months after the clinical effect is achieved. The effectiveness of contraception is determined, first of all, by compliance with the regimen of taking the drug. It is important that at the end of the drug course, the reproductive function is fully and immediately restored. Diane-35 is well tolerated, which allows it to be used as part of long-term drug courses without interruptions. Side effects (breast engorgement, headaches, hydration) are relatively rare. The drug has practically no effect on liver metabolism. As a rule, 3-4 months of pharmacotherapy using Diane-35 is enough for the disappearance of mild to moderate seborrhea, and increased oiliness of the hair disappears even earlier. It takes a longer time to resolve hirsutism (see above). In addition to androgenic, cyproterone acetate also has progestogenic activity. Against the background of taking Diane-35, the menstrual cycle becomes more regular, the pain of menstruation disappears, bleeding becomes less intense, which reduces the likelihood of developing iron deficiency anemia. The time of taking Diane-35 is not so important: the main thing is regularity and consistency (the drug should be taken at the same chosen time, optimally after a morning or evening meal). Before starting pharmacotherapy, a woman should undergo a medical examination, be tested for pregnancy, and exclude violations of the coagulation system. A long course of medication is the basis for conducting such examinations every six months. With the recent appearance of hirsutism or a sharp increase in its manifestations, it is necessary to consider other reasons for this development of events. Antibiotics of the penicillin series reduce the effectiveness of Diane-35.

Pharmacology

Combined low-dose monophasic oral contraceptive with antiandrogenic effect, containing estrogen - ethinyl estradiol and antiandrogen with progestogenic activity - cyproterone acetate.

Cyproterone acetate contained in Diana-35 inhibits the influence of androgens, which are also produced in the female body. Thus, it becomes possible to treat diseases caused by increased production of androgens or specific sensitivity to these hormones.

Against the background of taking Diane-35, the increased activity of the sebaceous glands, which plays an important role in the occurrence of acne and seborrhea, decreases. After 3-4 months of therapy, this usually leads to the disappearance of the existing rash. Excessive oiliness of hair and skin disappears even earlier. It also reduces hair loss, which often accompanies seborrhea. Diane-35 therapy in women of reproductive age reduces the clinical manifestations of mild forms of hirsutism; however, the effect of the treatment should be expected only after several months of use.

Along with the above-described antiandrogenic effect of cyproterone acetate, it also has a pronounced progestogenic effect.

The contraceptive effect of Diane-35 is based on the interaction of various factors, the most important of which are the inhibition of ovulation and changes in the secretion of cervical mucus.

The cycle becomes more regular, painful periods are less often observed, the intensity of bleeding decreases, as a result of which the risk of iron deficiency anemia decreases.

Pharmacokinetics

Cyproterone acetate

Suction

After taking Diane-35 cyproterone acetate is completely absorbed from the gastrointestinal tract. Bioavailability - 88%. After ingestion of 1 tablet of Diane-35 Cmax is reached after 1.6 hours and is 15 ng / ml.

Distribution

Cyproterone acetate is almost completely bound to plasma albumin, approximately 3.5-4.0% is in the free state. Since protein binding is nonspecific, changes in the level of sex steroid-binding globulin (SHBG) do not affect the pharmacokinetics of cyproterone acetate. Up to 0.2% of the dose of cyproterone acetate is excreted in breast milk.

Metabolism and excretion

The pharmacokinetics of cyproterone acetate is two-phase, T 1/2 is 0.8 h and 2.3 days, respectively, for the first and second phases. The total plasma clearance is 3.6 ml/min/kg. Biotransformed by hydroxylation and conjugation, the main metabolite is a 15β-hydroxyl derivative. It is excreted mainly in the form of metabolites with urine and bile in a ratio of 1: 2, a small part - unchanged with bile. T 1/2 for cyproterone acetate metabolites is 1.8 days.

Ethinylestradiol

Suction

After taking Diane-35, ethinylestradiol is rapidly and completely absorbed from the gastrointestinal tract. In the process of absorption and "first passage" through the liver, ethinylestradiol undergoes intensive metabolism, which leads to a bioavailability of approximately 45%, and its significant individual variability. After ingestion of 1 tablet of Diane-35 Cmax is approximately 80 pg / ml and is reached after 1.7 hours.

Distribution

Binding to proteins (albumin) of blood plasma is high (2% is in the plasma in a free form). V d is approximately 5 l/kg. Up to 0.02% of the dose of ethinyl estradiol is excreted in breast milk. Ethinylestradiol increases hepatic synthesis of SHBG and CCG (corticosteroid-binding globulin) during continuous administration. During treatment with Diane-35, the serum concentration of SHBG increased from approximately 100 nmol / l to 300 nmol / l and the serum concentration of CSH increased from approximately 50 μg / ml to 95 μg / ml.

Metabolism and excretion

The pharmacokinetics of ethinylestradiol is two-phase, with T 1/2 1-2 h (α-phase) and approximately 20 h (β-phase), respectively. Plasma clearance - about 5 ml / min / kg. Ethinylestradiol is excreted from the body as metabolites; about 40% - with urine, 60% - with bile.

Release form

Excipients: lactose monohydrate - 31.115 mg, corn starch - 18 mg, povidone - 2.1 mg, talc (magnesium hydrosilicate) - 1.65 mg, magnesium stearate - 0.1 mg.

Shell composition: sucrose - 19.371 mg, povidone 700,000 - 0.189 mg, macrogol 6000 - 2.148 mg, calcium carbonate - 8.606 mg, talc (magnesium hydrosilicate) - 4.198 mg, titanium dioxide - 0.274 mg, glycerol - 0.137 mg, mountain glycol wax - 0.05 mg, iron (II) oxide - 0.027 mg.

21 pcs. - blisters (1) - packs of cardboard.

Dosage

Diane-35 is taken orally 1 tablet / day. Dragees are taken without chewing and washed down with a small amount of liquid. The time of taking the drug does not play a role, but the subsequent dose should be taken at the same selected hour, preferably after breakfast or dinner.

Diane-35 intake is started on the 1st day of the cycle, using pills of the corresponding day of the week from the calendar package.

The daily intake of the drug is carried out using dragees from the calendar package sequentially in the direction of the arrow printed on the foil until all the dragees are taken. After the end of taking all 21 pills from the calendar package, a break is made in taking the drug for 7 days, during which menstrual bleeding occurs.

After 28 days from the start of taking the drug (21 days of admission and 7 days off), i.e. on the same day of the week as at the beginning of the course, continue taking the drug from the next package.

When switching from combined oral contraceptives, Diane-35 should be started the next day after taking the last pill with the active components of the previous drug, but in no case later than the next day after the usual 7-day break in taking (for drugs containing 21 pills) . Further according to the scheme described above. If the patient has taken the previous contraceptive daily for 28 days, Diane-35 should be started after taking the last inactive dragee.

When switching from contraceptives containing only gestagens ("mini-pill"), Diane-35 can be used without interruption. When using injectable forms of contraceptives, Diane-35 begins to be taken from the day the next injection is to be made. When switching from an implant - on the day of its removal. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the dragee.

After an abortion in the first trimester of pregnancy, a woman can start taking the drug immediately. In this case, the woman does not need additional methods of contraception.

After childbirth or abortion in the II trimester of pregnancy, the drug should be started on the 21-28th day. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

If a woman had a sexual life between childbirth or abortion and the start of taking Diane-35, then pregnancy should first be excluded or it is necessary to wait for the first menstruation.

A woman should take the missed pill as soon as possible, the next pill is taken at the usual time. If the delay is less than 12 hours, the reliability of contraception does not decrease. If the delay in taking the pills was more than 12 hours, the reliability of contraception may be reduced. It should be borne in mind that taking pills should never be interrupted for more than 7 days, and that 7 days of continuous pills are required to achieve adequate suppression of the function of the hypothalamic-pituitary-ovarian system.

If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the first and second weeks of taking the drug, then the woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next dragee is taken at the usual time. Additionally, you should use a barrier method of contraception for the next 7 days.

If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the third week of taking the drug, then the woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time ). The next dragee is taken at the usual time. In addition, taking pills from a new package should be started as soon as the current package is over, i.e. nonstop. It is most likely that the woman will not have withdrawal bleeding until the end of the second pack, but she may experience spotting or breakthrough bleeding on the days of taking the pills.

If a woman has had vomiting within 3 to 4 hours after taking Diane-35, absorption of the active substances may be incomplete. In this case, it is necessary to focus on the recommendations when skipping the dragee.

In order to delay the onset of menstruation, a woman should continue taking the pills from the new Diane-35 package immediately after taking all the pills from the previous one, without interrupting the intake. Dragees from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume taking Diane-35 from a new package should be after the usual 7-day break.

In order to move the day of the start of menstruation to another day of the week, a woman should shorten the next break in taking pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will have further spotting and breakthrough bleeding during the second pack (just as she would like to delay her period).

In the treatment of hyperandrogenic conditions, the duration of administration is determined by the severity of the disease. After the disappearance of symptoms, it is recommended to take Diane-35 for at least another 3-4 months. In the event of a relapse a few weeks or months after the completion of the course, repeated therapy with Diane-35 can be performed.

Overdose

Symptoms: nausea, vomiting, slight vaginal bleeding (in girls).

Treatment: carry out symptomatic therapy. There is no specific antidote.

Interaction

With the simultaneous use of Diane-35 with inducers of microsomal liver enzymes (hydantoins, barbiturates, primidone, carbamazepine and rifampicin; and, possibly, with oxcarbazepine, topiramate, felbamate and griseofulvin), the clearance of ethinylestradiol and cyproterone increases, which can lead to breakthrough uterine bleeding or decrease in the reliability of contraception.

With simultaneous use with ampicillins and tetracyclines, the contraceptive reliability of Diane-35 is reduced.

Side effects

From the endocrine system: in rare cases - engorgement, soreness, enlargement of the mammary glands and discharge from them, changes in body weight.

From the reproductive system: in rare cases - intermenstrual bleeding, changes in vaginal secretions, changes in libido.

From the side of the central nervous system: in rare cases - headache, migraine, decreased mood.

From the digestive system: in rare cases - nausea, vomiting.

Other: in very rare cases - poor tolerance to contact lenses, allergic reactions, the appearance of age spots on the face (chloasma).

These side effects may develop in the first few months of taking Diane-35 and usually decrease over time.

Indications

  • contraception in women with androgenization phenomena;
  • androgen-dependent diseases in women: acne (especially their pronounced forms, accompanied by seborrhea, inflammatory phenomena with the formation of nodes /papular-pustular acne, nodular cystic acne/), androgenetic alopecia and mild forms of hirsutism.

Contraindications

  • thrombosis and thromboembolism, incl. in history (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
  • conditions preceding thrombosis (including transient ischemic attacks, angina pectoris);
  • diabetes mellitus complicated by microangiopathies;
  • the presence of severe or multiple risk factors for venous or arterial thrombosis;
  • diseases or severe violations of the liver;
  • liver tumors (including history);
  • hormone-dependent malignant tumors, incl. tumors of the breast or genital organs (including history);
  • uterine bleeding of unknown etiology;
  • pancreatitis (including history), if it was accompanied by severe hypertriglyceridemia;
  • a history of migraine, which was accompanied by focal neurological symptoms;
  • lactation (breastfeeding);
  • pregnancy or suspicion of it;
  • hypersensitivity to the components of the drug.

If any of these conditions develop for the first time while taking Diane-35, the drug should be immediately discontinued.

Application features

Use during pregnancy and lactation

Diane-35 is contraindicated for use during pregnancy and lactation.

Application for violations of liver function

special instructions

Before starting the use of Diane-35, it is necessary to conduct a general medical examination (including the mammary glands and a cytological examination of cervical mucus), exclude pregnancy, disorders of the blood coagulation system. With prolonged use of the drug, preventive control examinations should be carried out every 6 months.

In the presence of risk factors, the potential risk and expected benefit of therapy should be carefully assessed and discussed with the woman before she decides to start taking the drug. With aggravation, intensification, or at the first manifestation of any of these conditions or risk factors, drug withdrawal may be required.

The approximate incidence of venous thromboembolism (VTE) when taking oral contraceptives with a low dose of estrogen (less than 50 micrograms of ethinyl estradiol) is up to 4 per 10,000 women per year, compared with 0.5-3 per 10,000 women who do not take oral contraceptives. At the same time, the frequency of VTE when taking combined oral contraceptives is less than the frequency of VTE associated with pregnancy (6 per 10,000 pregnant women per year).

The patient should be warned that with the development of symptoms of venous or arterial thrombosis, you should immediately consult a doctor. These symptoms include unilateral leg pain and/or swelling; sudden severe chest pain with or without radiating to the left arm; sudden shortness of breath; sudden onset of coughing; any unusual, severe, prolonged headache; increased frequency and severity of migraine; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; dizziness; collapse with/without partial seizure; weakness or very significant loss of sensation that suddenly appeared on one side or in one part of the body; movement disorders; symptom complex "acute" abdomen.

The relationship between taking combined oral contraceptives and arterial hypertension has not been established. If persistent arterial hypertension occurs, Diane-35 should be canceled and appropriate antihypertensive therapy prescribed. Reception of a contraceptive can be continued with the normalization of blood pressure.

If abnormal liver function occurs, Diane-35 may need to be temporarily discontinued until laboratory parameters return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.

Although combined oral contraceptives have an effect on tissue resistance to insulin and glucose tolerance, it is usually not necessary to adjust the dose of hypoglycemic drugs in patients with diabetes mellitus. Nevertheless, this category of patients should be under close medical supervision.

Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

If symptoms in women with hirsutism have developed recently or have increased significantly, other causes, such as an androgen-producing tumor, congenital adrenal dysfunction, should be considered in the differential diagnosis.

While taking Diane-35, irregular bleeding (spotting or breakthrough bleeding) can sometimes occur, especially during the first months of therapy. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately 3 cycles.

If irregular bleeding recurs or develops after previous regular cycles, then non-hormonal causes should be considered and adequate diagnostic measures taken to exclude malignant neoplasms or pregnancy. These may include diagnostic curettage.

In some cases, withdrawal bleeding may not develop during a break in taking the dragee. In case of irregular intake of pills or in the absence of two menstrual-like bleeding in a row, pregnancy should be excluded before continuing to take the drug.

Acne (pimples) often occurs against the background of impaired functions that are in the upper layers.

Usually the appearance of acne indicates diseases of the body, most often this is how problems with the endocrine system manifest themselves.

In cases where external acne medications do not help or their actions are mild, then the dermatologist prescribes a hormonal examination and, based on the tests, prescribes Diana 35.

Indications

The drug is prescribed only for girls and women.

The main reason for prescribing this drug is hormonal disbalance when the content of hormones, in particular the androgynous group, affects the violation of fat metabolism in the body. As a result, the production of sebum increases and sweating increases.

These factors lead to clogged pores and multiplication of bacteria, which provoke the appearance of acne and blackheads, which are amenable to complex treatment.

Often the problem manifests itself in and persists after puberty, aggravating depending on the phase of the menstrual cycle.

Why does Diana 35 help with acne?

Diane 35 contains cyproterone acetate, which lowers the production of androgens (male sex hormones), they are produced in the female body in excess.

That is why it becomes possible to treat acne and blackheads that appear against the background of an imbalance in this group of hormones.

While taking the drug, the level of excess hormones decreases, the hyperfunction of the sebaceous glands weakens, which affects the occurrence of acne, blackheads and seborrhea.

After a few months (3-4) of taking the drug, the condition improves, while at the same time the fat content of the hair and their loss decrease, also less hirsutism.

Many oral contraceptives of the combined group have this effect, but in the case of Diana 35, the effect is more pronounced. In parallel with this, the menstrual cycle is being adjusted, pains during menstruation are weakening.

Most often, this therapeutic effect is manifested in women from 20 to 40 years old, because Acne is not just a teen problem, women of childbearing age often encounter it, on average, 40% of the fair sex have a problem with acne, which Diana 35 helps to treat.

After undergoing treatment with this drug, most patients note the complete disappearance of acne. Therefore, if in the analyzes you have an increased level of male hormones, then Diana 35 will help in solving the problem by restoring the hormonal background of the body.

An effective fight against acne is possible only with complex treatment. When using preparations for internal use, do not forget about cosmetic skin treatment.

How to take Diana 35 correctly?

Before you start taking the drug, it is necessary to undergo a complete gynecological examination in order to identify health problems and hormone levels.

When treatment with this particular drug is indicated, only a doctor can prescribe treatment.

When you see your doctor, be sure to let him know if you have any of the following problems:

  • systematic smoking;
  • diabetes mellitus in you or your immediate family;
  • excess weight;
  • problems with blood pressure, heart or circulatory system;
  • migraine and epilepsy;
  • oncological diseases of the mammary glands in you and your immediate family;
  • diseases of the liver, intestines, skin, blood;
  • the presence of holosma (brown pigmentation on the skin).

If at least one of the problems manifested itself earlier or appeared while taking the drug, then it is necessary to inform the doctor about it, because the effectiveness of acne treatment and health status in the future depends on it.

Dosage and administration

The drug must be taken regularly in order to achieve the full therapeutic effect.

The package contains dragees in the amount of 21 pieces. In the package, the dragee is marked according to the day of the cycle (week) when it should be taken.

Need to take the drug according to the marked day at the same time, for simplicity, the direction of the arrows for receiving is also indicated. After 21 days, you must definitely take a break in order for menstruation to begin, and after the break, the drug is again taken according to the same scheme.

Reception of the first package of Diana 35 begins on the first day of the monthly cycle, in full accordance with the labeling by day, if, for example, bleeding began on Wednesday, then you should take a dragee signed as “Wednesday”.

If you combine acne treatment with contraception, then the first 3-5 days you need to additionally use barrier methods of contraception.

To achieve a therapeutic effect the drug is used for at least 4-6 months. Often, a doctor prescribes a course of treatment in accordance with the test results and may note the reception as he recovers, in case of a relapse, Diana 35 can again be prescribed, which will be taken according to the previously described scheme.

If you are using other oral contraceptives, the doctor will advise you on how to change the drug to obtain the therapeutic effect of Diane 35.

Two different hormonal contraceptives cannot be taken at the same time, due to the fact that it is dangerous to life and health.

Contraindications for taking this drug

For the use of the drug there are the following contraindications:
  • thrombosis acute or already treated;
  • cardiovascular diseases, heart attacks, angina pectoris, strokes, both acute and already treated;
  • diabetes mellitus of both types with impaired vascular function;
  • diseases of the liver, gallbladder, hepatitis, liver cancer;
  • oncological diseases of the mammary glands, genital organs, acute or in remission;
  • uterine bleeding, the cause of which is not determined;
  • pregnancy, lactation;
  • the presence of allergic reactions to the components of the drug.

At the first manifestations of diseases or side effects, immediately stop taking the drug and consult a doctor for other treatment.

Remember that Diana's reception is 35 does not protect against HIV infection or sexually transmitted infections. Never offer the drug to other people if it was prescribed for you.

If you are pregnant, then taking the drug may cause a miscarriage or the development of pathologies in the fetus. During lactation, the drug is prohibited due to the fact that there may be a loss of the ability to produce milk, and the risk of mastopathy increases. Separately, it should be noted that the drug is not prescribed for children and adolescents, it is also contraindicated after menopause.

Women with liver disease should not take the drug until the clinical parameters of the liver return to normal. For women with kidney problems, the drug is most often not prescribed due to the fact that the effect of the drug is not fully understood, how the kidneys will react to it is not known. For those women who smoke, the drug is not prescribed, the combination of nicotine and the medicinal components of Diane 35 can lead to the development of serious consequences, such as thrombosis or stroke.

Side effects caused by taking Diane 35

Tell your doctor right away if you notice changes in how you feel that you have not experienced before or have been associated with other medical conditions.

Side effects include:

  • headaches, dizziness;
  • engorgement, pain and fluid discharge from the breast;
  • violation of libido;
  • mood swings or lack of energy;
  • development of intolerance to contact lenses;
  • nausea or vomiting;
  • changes in vaginal discharge;
  • skin rashes that have not previously been observed;
  • swelling and urinary retention;
  • body weight difference, both its increase and decrease;
  • manifestation of hypersensitivity reactions to odors.

What is the price?

The cost of the drug varies depending on the pharmacy and the region within from 770 to 1100 rubles.

Diane 35 for acne: reviews of those taking the drug

Due to the fact that the drug has been used in medical practice against acne for a long time, there are many reviews about taking the drug, here are some of them:

Tatiana: Skin problems have been observed since the age of 17. She carried out traditional treatment at the dermatologist and cosmetologist, used external preparations. After 18 years, I turned to a gynecologist, who, after a complete examination and treatment of cervical erosion, was prescribed the drug Diana 35. The medicine began to help gradually, acne began to disappear, and the wounds from them healed. After 5 months, the problems almost completely disappeared, it remains only to carry out a series of procedures to cleanse the skin of the face and restore it. The contraceptive drug Diana 35 played a very important role in the treatment, because my hormonal background improved. Unfortunately, a few months after the cure, with a violation of nutrition, rest and hygiene of the skin of the face, the rash began to fade again, but now I know for sure that the dermatologist and gynecologist should prescribe the treatment for me.

Olga: I have been taking the drug for about 4 years, I am satisfied with the result. Both in terms of contraception and against acne. Although, of course, my skin did not become perfect, but as before, the rash before menstruation with large painful acne does not appear anymore. The effect appeared already in the second month and was fixed after 5 months.

Marina: Acne bothered me for several years. The dermatologist, to whom I turned, advised me to cleanse the intestines and the whole body of toxins. I sat on a terrible diet, lost weight, became haggard, went through a series of reading procedures, but there was no effect. Only after that I turned to a gynecologist-endocrinologist, who sent me to be tested for an androgynous complex, it turned out that I had problems with testosterone (such a male hormone), the indicator is not critical, but acne, most likely, because of it could be. They prescribed Diana 35 for me, I had to quit smoking, because you can’t drink medicine and smoke at the same time. In the first month, the skin began to improve, after 4 months the effect was stunning, however, in parallel with taking Diana 35, I went to the beautician. After taking the medicine for another 6 months, the skin was excellent, and then the rashes began again. The gynecologist-endocrinologist explained to me that the level of hormones has risen again and Diana needs to take it again.

The medicinal properties of the drug Diane 35 allow the treatment of acne and various skin diseases that appear due to hormonal imbalance. Treatment can only be prescribed by a doctor and it needs to be carried out for a long period of time, in parallel it is imperative to take care of the skin of the face by other means.

After undergoing a course of treatment, a stable result lasts for a long period of time, but like any hormonal disorder that cannot be completely overcome, the rashes can return, so the drug can and should be taken again.

You can continue taking the medicine for an unlimited period of time, it is important to monitor your health during and after taking it in order to prevent the development of side effects and serious illness.
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